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The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

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The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity c Glucose Reagent Kit contains Reagent 1 with ATP •2Na, NAD, G-6-PDH, and Hexokinase as reactive ingredients, and sodium azide as a preservative. The kit is available in two sizes: 400 tests per cartridge (10 cartridges per kit, 4000 tests per kit) and 1100 tests per cartridge (10 cartridges per kit, 11,000 tests per kit). The reagent container is made of black polypropylene with a black high density polyethylene closure.

The Alinity c Multiconstituent Calibrator Kit contains Cal 1 and Cal 2, prepared from a human-based matrix containing multiple analytes, including glucose, with sodium azide as a preservative. The calibrators are standardized for glucose using NIST SRM 965 and the ID-GC/MS reference method.

The Alinity c System is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. It uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration. The system features robotic sample handling, continuous reagent access, continuous bulk solution access, and priority sample loading on all carrier positions.

This document describes the analytical performance of the Alinity c Glucose Reagent Kit and the Alinity c System for measuring glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The studies evaluate various performance characteristics against predefined acceptance criteria to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.

The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.

Synermed IR-1200 Glucose Reagent

The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.

Synermed IR-1200 Chemistry Analyzer

The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.

The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synermed Glucose Reagent and Synermed IR-1200 Chemistry Analyzer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the performance of the Synermed Glucose Reagent on the Synermed IR-1200 Chemistry Analyzer. While it doesn't explicitly list "acceptance criteria" as a separate, pre-defined column, the "Results" sections and the discussions of "non-significant interference" imply the criteria used for evaluation. Therefore, I will reconstruct the table with implied acceptance criteria based on the reported results.

2. Sample Size Used for the Test Set and Data Provenance:

• Precision/Reproducibility:

  • Sample Size: 5 concentrations of pooled patient serum, with 80 measurements at each concentration (run in duplicate twice a day for twenty days). Total = 400 measurements (5 concentrations * 80 measurements/concentration). While 80 measurements per concentration are mentioned, it's 2 duplicates per day * 20 days.
  • Data Provenance: Not explicitly stated, but "pooled patient serum" suggests human biological samples. No mention of country of origin or whether it was retrospective/prospective.

• Linearity/Reportable Range:

  • Sample Size: 13 concentrations across the measuring range, with four replicates at each concentration. Total = 52 measurements (13 concentrations * 4 replicates). Sample preparation involved "intermixing a high serum pool with a low serum pool."
  • Data Provenance: Not explicitly stated. The use of "serum pool" implies human samples.

• Analytical Specificity (Interference):

  • Sample Size: Serum pools spiked with interferents at two analyte levels (80 mg/dL and 120 mg/dL glucose) and at two concentrations of interferent. Specific numbers of samples are not detailed beyond "serum pools."
  • Data Provenance: Not explicitly stated. Use of "serum pools" implies human samples.

• Detection Limit (LoB, LoD, LoQ):

  • Sample Size: Not explicitly stated, but the study "evaluated following CLSI EP17-A" suggests a scientifically rigorous approach with sufficient replicates, though the exact number isn't provided.
  • Data Provenance: Not explicitly stated.

• Comparison Studies (Method Comparison):

  • Sample Size: 115 samples for glucose. 15 of these were "modified to cover the entire claimed measuring range" by intermixing patient serum pools.
  • Data Provenance: Not explicitly stated, but "patient serum pools" and "patient serum samples" indicate human biological samples. No mention of country of origin or whether it was retrospective/prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes the performance of a quantitative laboratory diagnostic device (chemistry analyzer and reagent). For such devices, "ground truth" is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods, often traceable to international standards (e.g., NIST).
• Predicate Devices: Comparison to an already FDA-cleared device provides a benchmark.

The studies presented here rely on these types of "ground truth":

• For linearity, the "expected values" are derived from known dilutions.
• For comparison studies, the "ground truth" is the measurement obtained from the predicate device (Hitachi 717 chemistry analyzer) using the same previously cleared reagent systems.

Therefore, no human experts were used to establish a subjective "ground truth" in the way they might be for interpreting medical images. The "ground truth" is analytical, derived from established laboratory methodologies and reference measurements. The Synermed IR Cal II calibrator is stated to be traceable to NIST standard number 917-C, which provides a form of metrological ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As explained above, the "ground truth" is analytical/measurement-based, not based on human interpretation or consensus. There is no need for an adjudication method for these types of studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on human performance. This document concerns a chemistry analyzer and reagents, which are distinct from image-based AI diagnostics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, all presented studies are standalone (algorithm only). The Synermed IR-1200 Chemistry Analyzer is an automated instrument. The performance reported (precision, linearity, specificity, detection limits, method comparison) reflects the intrinsic analytical capabilities of the device itself, without human interpretation or intervention affecting the measurement results. The results are quantitative outputs directly from the instrument.

7. Type of Ground Truth Used:

The ground truth used is primarily measurement-based and comparative:

• Reference Values/Standards: For linearity, expected values from known dilutions. For calibration, traceability to NIST standards.
• Predicate Device Measurements: In the method comparison study, the measurements from the predicate Hitachi 717 chemistry analyzer serve as the comparative ground truth.
• Defined Analytical Procedures: Ground truth for precision, linearity, and detection limit studies are established through rigorous adherence to CLSI (Clinical and Laboratory Standards Institute) protocols, which are industry standards for analytical validation.

8. Sample Size for the Training Set:

This document describes the validation of a chemistry analyzer and reagent, which are based on established chemical reactions and spectrophotometric measurements. There is no mention of a "training set" in the context of machine learning or AI model development because the device does not employ a learning algorithm that requires training. Its operational parameters are based on fixed scientific principles and engineering designs.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples.

The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders.

The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays.

For in vitro diagnostic use only.

Not Found

This document is an FDA 510(k) clearance letter for the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer, along with associated reagents and calibrators, for measuring glucose, sodium, potassium, and chloride in serum and plasma. The letter does not contain the detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be required to fully answer your request.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the FDA has deemed the device substantially equivalent to existing devices, implying that the performance presented in the 510(k) submission met the acceptance criteria by demonstrating performance comparable to the predicate device. However, the specific acceptance criteria and detailed study findings are not included in this publicly available letter.

Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or how ground truth was established for training and test sets.

The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It includes the indications for use but does not provide the underlying performance studies or the specific acceptance criteria and results from those studies.

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The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.

The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell Carcinoma.

The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.

The instrument includes of the following main parts;

• . Sampling Arm (for sample addition to cuvettes)
• Reagent Arm (for reagent addition to cuvettes) .
• Reaction Station (cuvettes) .
• Sample Plate Station (for loading samples) .
• Reagent Plate Station (for on board reagents) .
• . Photometer (for reaction analysis reading)
• Wash Station (for cleaning of reaction cuvettes) .
• Electronic Boards (for controlling the open functions) .

The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.

The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.

1. Table of Acceptance Criteria and Reported Device Performance

Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride

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UniCel DxC SYNCHRON Systems Glucose reagent (GLUH), when used in conjunction with UniCel® DxC 600/800 SYNCHRON System(s) and SYNCHRON Systems AQUA CAL 1 and 3, is intended for the quantitative determination of glucose concentration in human serum. plasma, urine or cerebrospinal fluid (CSF).

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

GLUH reagent is used to measure the glucose concentration by a timed endpoint method. In the reaction, hexokinase (HK) catalyses the transfer of a phosphate group from adenosine triphosphate (ATP) to glucose to form adenosine diphosphate (ADP) and glucose-6phosphate. The glucose-6-phosphate is then oxidized to 6-phosphogluconate with the concomitant reduction of ß-nicotinamide adenine dinucleotide (NAD) to reduced ßnicotinamide adenine dinucleotide (NADH) by the catalytic action of glucose-6-phosphate dehydrogenase (G6PDH).

The UniCel® DxC 600/800 SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 100 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of glucose in the sample and is used by the System to calculate and express glucose concentration.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the "claimed" limits for some performance characteristics, implying these are the acceptance criteria. For others, the criteria are implied by the study design (e.g., linearity within a range, interference values less than or equal to a certain threshold).

• Serum: Slope 0.982, Intercept -1.02, R 1.000
• CSF: Slope 0.978, Intercept 1.25, R 1.000
• Urine: Slope 0.989, Intercept 2.08, R 1.000

UniCel DxC 800:

• Serum: Slope 0.999, Intercept -1.60, R 1.000
• CSF: Slope 1.002, Intercept -0.61, R 1.000
• Urine: Slope 0.973, Intercept 2.86, R 1.000
  (All reported R-values are 1.000, indicating excellent correlation) |
  | Anticoagulant Effects | Minimal impact on glucose measurements (Deming Regression slope ~1, intercept ~0, R ~1). | DxC600:
• Sodium Heparin: y= 0.983 + 0.849, R= 0.999
• Lithium Heparin: y= 0.994 + 0.393, R= 0.999
• Sodium Fluoride/Potassium Oxalate: y= 0.995 + 1.007, R= 0.999

DxC800:

• Sodium Heparin: y= 0.998 - 0.172, R= 0.999
• Lithium Heparin: y= 1.02 - 2.476, R= 1.000
• Sodium Fluoride/Potassium Oxalate: y= 1.012 - 0.302, R= 0.999
  (All R-values are 0.999 or 1.000, indicating strong correlation) |
  | Precision | Within run SD ≤ 2.0 mg/dL, Total SD ≤ 3.0 mg/dL. Within run %CV ≤ 2.0%, Total %CV ≤ 3.0% (at or above changeover value of 100.0 mg/dL). | Within Run (DxC 600 & 800): Max SD observed was 7.5 mg/dL (Serum Pool3 DxC 800) and max %CV was 3.6% (Serum Pool 1 DxC 600 & 800, Urine Pool 1 DxC 600, CSF Pool 1 DxC 600). Most values for samples >=100 mg/dL are well within claimed limits.

Total (DxC 600 & 800): Max SD observed was 9.4 mg/dL (Serum Pool3 DxC 800) and max %CV was 5.7% (Urine Pool 1 DxC 600). Most values for samples >=100 mg/dL are well within claimed limits.
(Performance across various sample types and concentrations generally meets or comes close to the claimed limits, with some low-concentration samples showing higher %CV as expected.) |
| Analytical Sensitivity | LoB, LoD, LoQ values ≤ 5 mg/dL. | LoB: Serum 0.19 mg/dL, CSF 0.17 mg/dL, Urine 0.19 mg/dL
LoD: Serum 1.74 mg/dL, CSF 1.68 mg/dL, Urine 1.78 mg/dL
LoQ: Serum 3.78 mg/dL, CSF 3.67 mg/dL, Urine 3.69 mg/dL
(All reported values are well below the 5 mg/dL criterion, indicating high sensitivity.) |
| Linearity | Linear between 5 and 700 mg/dL. | The data "substantiates GLUH test is linear between 5 and 700 mg/dL." Linear equations for DxC 600 and DxC 800 for Serum, CSF, and Urine demonstrate good linearity (slopes near 1 and small intercepts). |
| Interferences | Interference values ≤ ± 6 mg/dL or 10% (crossover value 60 mg/dL). | For low-level glucose pools, the mg/dL difference from target and % recovery (relative to 10% tolerance from 60 mg/dL) are generally within acceptable limits. For mid and high-level pools, % recovery values are consistently between 96.5% and 103.5%, mostly within 10% of target.
e.g., Hemoglobin (500 mg/dL), Bilirubin (24 mg/dL), Lipemia (3+/4+), Ascorbic Acid (6.0 mg/dL), Urea (500 mg/dL), Uric Acid (40 mg/dL), EDTA (16 mg/dL), Creatinine (40 mg/dL) all passed the interference criteria. |
| Reagent Stability | Stable on board for 30 days. | Testing established that the GLUH reagent is stable on board for 30 days. Recovered values fell within expected ranges over the testing period. |
| Calibration Stability | 14 days. | The assay was calibrated at 14-day intervals during reagent stability testing, implying successful performance over this period. |
| Sample Dilution | Saline chosen as appropriate diluent, no issues observed. | Saline was chosen as the appropriate diluent, and "there was no issue or effect observed when verifying saline as an appropriate sample diluent." |

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison:
  • Serum (DxC 600 & 800): 120 samples each (total 240)
  • CSF (DxC 600 & 800): 100 samples each (total 200)
  • Urine (DxC 600 & 800): 117 samples each (total 234)
  • Total for Method Comparison: 674 samples.
• Anticoagulant Studies:
  • Sodium Heparin: 79 samples (DxC600), 58 samples (DxC800)
  • Lithium Heparin: 79 samples (DxC600), 58 samples (DxC800)
  • Sodium Fluoride/Potassium Oxalate: 79 samples (DxC600), 58 samples (DxC800)
  • Total for Anticoagulant Studies: (3 * 79) + (3 * 58) = 237 + 174 = 411 samples. (Stated "Over 50 patient specimens with glucose concentrations spanning the analytical range" for each anticoagulant type, then provides N for each DxC system. The cumulative N suggests that these are unique patient specimens across the anticoagulant types but not necessarily all unique for DxC600 vs DxC800)
• Precision: 80 data points for each sample type (Control 1, Control 2, Control 3, Pool 1, Pool 2, Pool 3) across Serum, Urine, and CSF, for both DxC 600 and DxC 800. This refers to the number of measurements rather than unique patient samples.
• Analytical Sensitivity (LoB, LoD, LoQ): "Multiple urine, CSF and serum pools were run over multiple days". Specific number of samples not given, but refers to "pools."
• Linearity: "Multiple replicates of the pools over the range of the assay." Specific number of samples not given, but refers to "pools."
• Interferences: "Patient serum pools" used for low, mid, and high glucose levels. Specific number of patient samples not given, but implies multiple pools.
• Data Provenance: The document explicitly states "patient correlation studies were conducted using... patient samples" and "paired plasma and serum samples from healthy volunteers." It doesn't specify country of origin but implies clinical laboratory settings. The studies are described as conducted by Beckman Coulter, Inc., suggesting internal testing. The nature of these studies (evaluating device performance against a predicate and known standards) indicates these are primarily prospective data collections for device validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts) is generally not applicable or stated for in vitro diagnostic devices like a glucose reagent. The "ground truth" for clinical chemistry assays is established by the reference method (the predicate device in this case) and established analytical techniques and standards (e.g., standard concentrations, known interference levels). Medical professionals use the results, but they don't establish the "ground truth" for the device's technical performance.

4. Adjudication Method

Not applicable for this type of in vitro diagnostic device study. Adjudication methods are typically used in studies involving subjective interpretation, like image analysis by multiple readers.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, which is not relevant for an automated glucose reagent.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are for the standalone performance of the UniCel DxC SYNCHRON Systems Glucose reagent (GLUH) itself, as implemented on the UniCel DxC 600/800 SYNCHRON Systems. The performance data presented (precision, linearity, sensitivity, interference) are direct measurements of the reagent's analytical capability. The method comparison studies compare this standalone performance to that of a predicate device.

7. Type of Ground Truth Used

The ground truth for the test set was established using:

• Predicate Device Measurements: For method comparison, the predicate device (SYNCHRON Glucose (GLU) or GLUCm) provided the comparative truth.
• Known Concentrations/Reference Standards: For studies like linearity, precision, and analytical sensitivity, the ground truth was based on samples with precisely known glucose concentrations (e.g., control materials, spiked samples, dilutions of high-concentration samples).
• Spiked Samples: For interference studies, known interfering substances were added to patient serum pools to create controlled samples with expected values.
• Paired Samples: For anticoagulant studies, serum samples (representing the true value) were compared with plasma samples prepared with different anticoagulants.

8. Sample Size for the Training Set

This document only describes performance testing for device validation and substantial equivalence with a predicate device. It does not refer to a "training set" in the context of machine learning. The "training" for such an in vitro diagnostic device involves the chemical formulation of the reagent itself and the engineering of the analyzer system, which would be subject to extensive R&D and internal testing, but not typically documented as a distinct "training set" in this manner for regulatory submission.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, there isn't a "training set" in the machine learning sense for this device. The development and optimization of the reagent and system would rely on standard chemical and analytical laboratory practices to ensure accurate and reliable measurements.

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The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays, such as glucose, sodium, potassium, and chloride, for clinical use in physician office laboratories or clinical laboratories. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ACE Glucose Reagent is intended for the quantitative determination of glucose in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Ion Selective Electrode (ISE) module on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems is used to measure concentrations of sodium, potassium, and chloride in undiluted serum and lithium heparin plasma. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Alera Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of general chemistry assays for clinical use in physician office laboratories or clinical laboratories. The ACE Alera Clinical Chemistry System consists of a bench-top analyzer and an internal computer. The bench-top analyzer includes a single pipettor (syringe module/fluid arm/probe), a temperature-controlled reagent compartment, a reaction wheel and a holographic diffraction grating spectrophotometer.

In the ACE Glucose Reagent assay, glucose in serum or heparin plasma reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.

The ACE Ion Selective Electrode (ISE) Module, as part of the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, uses a potentiometric method via ion-specific electrodes to simultaneously measure sodium, potassium and chloride in undiluted serum. Ion-specific membranes measure the difference in ionic concentrations between an inner electrolyte solution and the sample. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. A two-point calibration utilizes ACE CAL A and CAL B undiluted ISE Calibration Solutions with precisely known ion concentrations. The measured voltage difference of the sample and the CAL A and CAL B solutions determines the ion concentration in the sample on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems.

The device is the ACE Alera Clinical Chemistry System, ACE Glucose Reagent, and ACE Ion Selective Electrode (ISE) Module. The study assesses the performance of these components, focusing on the quantitative measurement of glucose, sodium, potassium, and chloride.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets that the device must meet in a formal, quantifiable way (e.g., "Accuracy must be > 95%"). Instead, the study aims to demonstrate substantial equivalence to predicate devices, showing that the performance of the ACE Alera system is comparable to established systems. The performance data presented focuses on precision (reproducibility) and method comparison with existing devices.

Since specific numerical acceptance criteria were not listed, one reasonable interpretation for implied acceptance criteria for laboratory diagnostic devices typically includes:

• Acceptable Precision: Coefficients of Variation (CV) or Standard Deviations (SD) for within-run and total precision across different concentration levels should be within generally accepted laboratory limits for each analyte. For clinical chemistry, these are often defined considering medical usefulness.
• Acceptable Method Agreement: Linear regression analysis (slope, intercept, correlation coefficient) and standard error between the new device and a reference method (or predicate device) should indicate good agreement. Slopes close to 1, intercepts close to 0, and high correlation coefficients (e.g., >0.975) are generally desired.
• No Significant Interference: The device should not be significantly affected by common interfering substances (icterus, hemolysis, lipemia, ascorbic acid) at clinically relevant levels.

Here's the performance data as reported, which serves as the evidence that these implicit acceptance criteria are met:

The study essentially acts as a validation against these implied criteria, demonstrating that the ACE Alera system's performance is acceptable for its intended use, comparable to the predicate devices.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision Studies: The document does not explicitly state the number of individual sample replicates for the core (non-POL) precision studies. However, for the POL Precision studies, for each analyte (Glucose, Sodium, Potassium, Chloride), there were 3 samples tested in each of 4 labs (In-House and 3 POLs). The tables show means, within-run, and total standard deviations/CVs, which typically imply multiple replicates per sample (e.g., 20 or more replicates are common in such studies).
• Method Comparison Studies:
  • Glucose: n = 46 samples for each of the three POL comparisons.
  • Sodium: n = 42 samples for each of the three POL comparisons.
  • Potassium: n = 43 samples for each of the three POL comparisons.
  • Chloride: n = 41 samples for each of the three POL comparisons.
• Data Provenance: The method comparison data is identified as "(2012 Data)" and collected from an "In-House" lab comparing against "ACE Alera system POL" data from three different Physician Office Laboratories (POLs 1, 2, 3), suggesting multi-center evaluation within the United States. The data is retrospective in the sense that it's reported for a 510(k) submission, but the studies themselves would have been conducted prospectively as a part of the device validation. The term "POL" indicates that these are real-world, clinical laboratory settings.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no human experts establishing ground truth in the context of interpretation for these types of in vitro diagnostic devices. The "ground truth" or reference values for chemical assays like glucose, sodium, potassium, and chloride are established by:

• Reference Methods: Often, a more established or gold-standard laboratory analyzer (in this case, the predicate ACE system in the In-House lab) is used to generate the "reference" values for comparison.
• Certified Reference Materials: Calibrators and controls with precisely known concentrations are used to calibrate and verify the accuracy of the instruments.

The qualifications of personnel operating these instruments are typically trained medical technologists or clinical laboratory scientists, but they do not establish "ground truth" in the way an expert radiologist might interpret an image.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1 consensus) are used for subjective interpretations, such as medical image analysis, where human experts might disagree. For quantitative chemical measurements, the comparison is directly between numerical results from different instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human interpretation of "cases" or "reads" in the way an MRMC study would evaluate.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are essentially standalone performance evaluations of the ACE Alera Clinical Chemistry System, the ACE Glucose Reagent, and the ACE Ion Selective Electrode (ISE) Module. The tables show the performance characteristics (precision, method comparison, interference) of the device itself in generating quantitative results. Human involvement is limited to operating the instrument, performing quality control, and routine maintenance, not subjective interpretation of results. The output (e.g., glucose concentration) is a direct numerical value from the instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the test set (the samples used in the method comparison studies) was established by comparison against a legally marketed predicate device, the Alfa Wassermann ACE system (specifically the ACE plus ISE/Clinical Chemistry System, K930140, K933862), effectively treating the predicate device's measurements as the reference standard. This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning algorithm. For clinical chemistry analyzers, the "training" analogous to machine learning would be:

• Instrument Calibration: The device is calibrated using commercially available calibrator solutions with known concentrations. The specific number of calibration points is not detailed but is typically specified by the manufacturer.
• Reagent Development and Optimization: The reagents themselves (like ACE Glucose Reagent) undergo extensive development and optimization, which involves testing on numerous samples to establish their performance characteristics (e.g., linearity, stability, interference). The exact sample sizes used during this development are not provided in this regulatory summary.

9. How the Ground Truth for the Training Set Was Established

As above, for an IVD analyzer, the "ground truth" for calibration or reagent development typically relies on:

• Certified Reference Materials: These are materials with highly accurate and traceable analyte concentrations, used to set the instrument's measurement scale.
• Validated Reference Methods: Established laboratory methods, often more complex or time-consuming, that are known to be highly accurate and precise for measuring the analyte.

The document implies that the ground truth for comparison samples was the predicate ACE system, and it is reasonable to assume that the calibration and internal controls for the ACE Alera system would rely on industry-standard reference materials and methods to establish accurate known values.

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Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen Electrode. Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample. Mission manufactures reagents intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM). All CX® & CX® Delta Systems that measure glucose utilize the same measurement method and reagent. The reagent is intended for use on equivalent OEM Instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device meets these criteria.

Acceptance Criteria and Device Performance for Mission Diagnostic Glucose Reagent

This medical device is an in-vitro diagnostic reagent intended for the quantitative determination of glucose in various biological samples (serum, plasma, CSF, and urine) on Beckman Synchron CX® & CX® Delta Systems. The goal of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (Beckman PN 443355 Glucose Reagent). Therefore, the acceptance criteria are implicitly tied to demonstrating comparable performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a glucose reagent intended to be substantially equivalent to an existing one, the "acceptance criteria" are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to show that the Mission Glucose Reagent performs similarly to the predicate Beckman reagent. The reported performance metrics are designed to demonstrate this similarity across various aspects.

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Ask a specific question about this device

Ask a specific question about this device